Anchor Device and Method

ABSTRACT

Some embodiments of an anchor device may include bendable anchor mechanism that is deployable in a subcutaneous layer to releasably secure the anchor device to a patient&#39;s body. Certain embodiments of the anchor mechanism may include one or more barbs that flexibly bend in response to an insertion or removal force. As such, the anchor mechanism may be inserted into a subcutaneous layer, and removed from the subcutaneous layer, without the need for a separate actuation device to extend or retract the barbs.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/406,150 filed on May 8, 2019, which is a continuation of U.S.application Ser. No. 15/171,540, filed Jun. 2, 2016 (now U.S. Pat. No.10,293,140), which is a continuation of U.S. application Ser. No.14/293,125 filed Jun. 2, 2014 (now U.S Pat. No. 9,381,323), which is acontinuation of U.S. application Ser. No. 13/211,625 filed on Aug. 17,2011 (now U.S. Pat. No. 8,771,232), which is a continuation of U.S.application Ser. No. 12/553,555 filed on Sep. 3, 2009 (now U.S. Pat. No.8,016,813), which is a division of U.S. application Ser. No. 11/372,283filed on Mar. 9, 2006 (now U.S. Pat. No. 8,016,794), the contents ofthese prior applications being incorporated herein by reference.

TECHNICAL FIELD

This document relates to an anchor device, such as an anchor device foruse in temporary placement of a catheter or other medical device.

BACKGROUND

Venous, arterial, and body fluid drainage catheters are commonly used byphysicians. For example, such catheters may be used to temporarily gainaccess to the vascular system for introducing pharmaceutical agents, fornutrition or fluids, for hemodynamic monitoring, and for blood draws.Alternatively, catheters can be used for drainage of fluid collectionsand to treat infection. Following introduction into the patient, thecatheter is typically secured to the patient using a tape patch or bysuturing an attached hub to the skin.

SUMMARY

Some embodiments of an anchor device may include a bendable anchormechanism that is deployable in a subcutaneous layer to releasablysecure the anchor device to a patient's body. Certain embodiments of theanchor mechanism may include one or more barbs that flexibly bend inresponse to an insertion or removal force. As such, the anchor mechanismmay be inserted into a subcutaneous layer, and removed from thesubcutaneous layer, without the need for a separate actuation device toextend or retract the barbs.

In some embodiments, an anchor device may include an elongate bodyhaving a body wall that at least partially defines a lumen. The devicemay also include a subcutaneous anchor mechanism coupled to the elongatebody. The subcutaneous anchor mechanism may have one or morenon-retractable barbs that extend away from the body wall when in adeployed orientation in a subcutaneous layer. The non-retractable barbsmay be flexibly bendable to a removal orientation when the anchormechanism is withdrawn from the subcutaneous layer and out through adermis layer. In one aspect, the elongate body may be a catheterconfigured to provide access to a patient's body. In another aspect, theelongate body may be a sleeve body configured to slidably receive acatheter or a medical instrument.

In some embodiments, a subcutaneous anchor mechanism may include a baseattachable to a medical device. The mechanism may also include at leastone non-retractable barb coupled to the base. The non-retractable barbmay extend from the base such that, when the base is attached to themedical device, the non-retractable barb extends away from the medicaldevice when in a deployed orientation in a subcutaneous layer. Thenon-retractable barb may be flexibly bendable to a removal orientationwhen the non-retractable barb is withdrawn from the subcutaneous layerand out through a dermis layer.

In some embodiments, an anchor device may include an elongate bodyhaving a body wall that at least partially defines a lumen. The devicemay also include means for subcutaneously anchoring the elongate body toa portion of skin. The subcutaneous anchor means may be coupled to theelongate body. The subcutaneous anchor means may include means fornon-retractably withdrawing from a deployed orientation in asubcutaneously layer to a bent orientation when passing through a dermislayer. In one aspect, the means for non-retractably withdrawing maycomprise one or more non-retractable barbs that extend away from thebody wall when deployed in the subcutaneous layer.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description below. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a side view of an embodiment of an anchor catheter having ananchor mechanism attached to the catheter.

FIG. 2 is an end view of the anchor catheter shown in FIG. 1.

FIG. 3 is a side view of an embodiment of an anchor sleeve having ananchor mechanism attached to the anchor sleeve, without a catheter orother device inserted therein.

FIG. 3A is an end view of the anchor sleeve shown in FIG. 3.

FIG. 4 is a side view of the anchor catheter shown in FIG. 1 duringinsertion into a patient.

FIG. 5 is a side view of the anchor catheter shown in FIG. 1 followinginsertion into a patient.

FIG. 6 is a side view of the anchor catheter shown in FIG. 1 duringremoval from the patient.

FIG. 7 is a side view of the anchor sleeve shown in FIG. 3 duringinsertion into a patient.

FIG. 8 is a side view of the anchor sleeve shown in FIG. 3 followinginsertion into a patient.

FIG. 9 is a side view of the anchor sleeve shown in FIG. 3 duringremoval from the patient.

FIG. 10 is a side view of an embodiment of an anchor mechanism.

FIG. 11 is a side view of an alternative embodiment of an anchormechanism.

FIG. 12 is a side view of an alternative embodiment of an anchormechanism.

FIG. 13 is a side view of the anchor sleeve of FIG. 12 and a catheteradvanced into a patient's blood vessel.

FIG. 14 is a side view of a further embodiment of an anchor mechanism,attached to a medical device shown in phantom lines.

FIG. 15 is a side view of an embodiment of a barb of an anchormechanism.

FIG. 16 is a side view of a further embodiment of a barb of an anchormechanism.

FIG. 17 is a side view of an alternative embodiment of an anchor sleeveincluding an adhesive portion used to secure an inserted catheter.

FIG. 18 is a top view of the anchor sleeve shown in FIG. 17.

FIG. 19 is a side view of an embodiment of a split anchor sleeve havingadhesive tabs extending from the split.

FIG. 20 is a top end view of the anchor sleeve shown in FIG. 19.

FIG. 21 is a side view of another embodiment of an anchor sleeve havingan anchor mechanism secured in the anchor sleeve wall.

FIG. 22 is a top end view of the anchor sleeve shown in FIG. 21.

FIG. 23 is a perspective view of an embodiment of an anchor mechanismhaving an individual barb attachable to a catheter, anchor sleeve orother medical device.

FIG. 24 is a perspective view of an alternative embodiment of an anchormechanism having an a plurality of barbs attachable to a catheter,anchor sleeve or other medical device.

Like reference symbols in the various drawings indicate like elements.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1-2, some embodiments of an anchor catheter 10 mayinclude an anchor mechanism in an unstressed configuration prior tobeing introduced into a patient. The anchor catheter 10 may include acatheter body 12 to which the anchor mechanism 22 is coupled. The anchormechanism 22 may include a base 26 which extends at least partiallyaround the catheter body 12 and includes one or more barbs 24. The base26 may be permanently or releasably coupled to the catheter body 12using, for example, adhesive, ultrasonic welding, compression fit,frictional engagement, internal engagement spikes, or the like. In thisembodiment, the anchor mechanism 22 includes two barbs 24. At least thebarb 24, and in some embodiments the entire anchor mechanism 22, is madefrom a nitinol material which has been processed to exhibitsuperelasticity below or at about a normal human body temperature, suchas below or at about 37 degrees C. These superelasticity characteristicspermit the barbs 24 to flex during insertion into a subcutaneous region,to flex during removal from the patient's skin, and (in somecircumstances) to return to its unstressed shape. In these embodiments,the barbs 24 may be non-retractable so that such flexing action mayoccur from the insertion and removal force applied to the catheter 12 orother medical device, without the need for a separate actuation deviceto fully retract the barbs 24 into a cavity.

In one embodiment, the anchor mechanism 22 may be formed from a lengthof nitinol tubing from which a portion has been cut away using lasercutting, electro chemical machining (ECM), electrical dischargemachining (EDM), water jet or other machining process. As such, the base26 may be integrally formed with the barbs 24. In these embodiments, thebarbs 24 may be thermo-mechanically trained to extend away from theplane of the outer wall 30 of the catheter 12, as described in greaterdetail below. It should be understood that, in the embodiments in whichthe barbs 24 comprise a nitinol material, the barbs 24 may be formedfrom a length of nitinol wire or from a sheet of nitinol material. Thenitinol material may comprise, for example, Nickel Titanium (NiTi),Niobium Titanium (NbTi), or the like. Alternatively, at least the barbs24, and in some circumstances the entire anchor mechanism 22, maycomprise a metal material such as stainless steel, spring steel,titanium, MP35N and other cobalt alloys, or the like.

In another embodiment, some or all of the anchor mechanism 22 maycomprise a bio-compatible polymer material that is configured toelastically flex during insertion into a subcutaneous region andconfigured to elastically flex or plastically deform during removal fromthe patient's skin. For example, the anchor mechanism can bethermoformed or otherwise molded from a PEEK material, a polyurethanematerial, a polyethylene material, a polyimide material, or anotherbio-compatible polymer material. In some embodiments, the barbs 24 mayhave grooves or notches formed therein to facilitate the proper flexingor deformation during insertion into the subcutaneous region or removalfrom the patient's skin, as described in more detail below.

Still referring to FIGS. 1-2, the barbs 24 may extend away from theplane of the outer wall 30 of the catheter body 12. The catheter body 12may define a catheter wall outer diameter 14 and thickness 18 aredefined, as is a catheter lumen 20. As shown in FIG. 1, some embodimentsof the catheter body 12 may comprise a wall pocket 28 to receive thebarbs 24 in the event the barbs forced against the outer wall 30. Inthese embodiments, the wall pocket 28 may serve to reduce the likelihoodof trauma to the patient's skin during insertion by providing a space toaccommodate one or more barbs 24.

Referring to FIGS. 3-3A, some embodiments of an anchor sleeve 100 mayinclude an anchor mechanism 110 coupled thereto. The anchor sleeve 100may comprise a sleeve body 102 to slidably receive a medical device(e.g., instrument, catheter, needle, etc.) therethrough. The anchorsleeve 100 may define a longitudinal dimension 107, a proximal end 106,a distal end 108 and a lumen 104. The lumen 104 may define an innerdiameter 105 that is shaped and sized to slidably receive a catheter 116(FIG. 7). Some embodiments of the sleeve body 102 may comprise a wallpocket (not shown in FIG. 3) in the outer wall 101 to receive the barbs112 in the event the barbs 112 are forced against the outer wall 101.

The anchor mechanism 110 may include a base 114 that at least partiallyextends around the outer diameter 109 of the sleeve body 102. The anchormechanism 110 may include one or more barbs 112 that extend from theplane of the outer wall 101 of the sleeve body 102. In this embodiment,the anchor mechanism 110 includes two barbs 112. The one or more barbs112, and in some embodiments the entire anchor mechanism 110, can bemade from nitinol material which has been processed to exhibitsuperelasticity below or at about a normal human body temperature, suchas below or at about 37 degrees C. Such superelasticity characteristicspermit the barbs 112 to flex during insertion into a subcutaneousregion, to flex during removal from the patient's skin, and (in somecircumstances) to return to its unstressed shape. In these embodiments,the barbs 112 may be non-retractable so that such flexing action mayoccur from the insertion and removal force applied to the sleeve body102 or other medical device, without the need for a separate actuationdevice to fully retract the barbs 112 into a cavity. As previouslydescribed, the anchor mechanism 110 may be formed from a length ofnitinol tubing from which a portion has been cut away using lasercutting, ECM, EDM, water jet or other machining process. Also aspreviously described, the barbs 112 may be thermo-mechanically trainedto extend away from the plane of the outer wall 101 of the sleeve body102. It should be understood that, in the embodiments in which the barbs112 comprise a nitinol material, the barbs 112 may be formed from alength of nitinol wire or from a sheet of nitinol material.Alternatively, at least the barbs 112, and in some circumstances theentire anchor mechanism 110, may comprise a metal material such asstainless steel, spring steel, titanium, MP35N and other cobalt alloys,or the like.

In another embodiment, some or all of the anchor mechanism 110 maycomprise a bio-compatible polymer material that is configured toelastically flex during insertion into a subcutaneous region andconfigured to elastically flex or plastically deform during removal fromthe patient's skin. For example, the anchor mechanism may bethermoformed or otherwise molded from a PEEK material, a polyurethanematerial, a polyethylene material, a polyimide material, or anotherbio-compatible polymer material. As described in more detail below, thebarbs 112 may have grooves or notches formed therein to facilitate theproper flexing or deformation during insertion into the subcutaneousregion or removal from the patient's skin.

Referring to FIGS. 4-6, the anchor catheter 10 previously described inconnection with FIGS. 1-2 may be introduced into a patient so that theanchor mechanism 22 may releasably secure the catheter body 12 to thepatient. As previously described, the insertion force applied to thecatheter body 12 or other medical device may cause at least a portion ofthe anchor mechanism 22 to flex during insertion into a subcutaneousregion, and the removal force applied to the catheter body 12 or othermedical device may cause at least a portion of the anchor mechanism 22to flex or deform during removal from the patient's skin. Thus, theanchor mechanism 22 may be self-actuated without the need for a separateactuation device to extend or retract the barbs 24.

As shown in FIG. 4, the anchor catheter 10 may be introduced through apatient's skin prior to commencement of a medical procedure or othertreatment. For example, the anchor catheter 10 may penetrate the dermis118 and subcutaneous layer 120 through a small incision made by aphysician, and in some cases a dilation instrument may be used toadvance the catheter 10 toward the targeted vessel. As a result of aninsertion force applied to the catheter body 12 by the physician, thebarbs 24 may be temporarily flexed from their unstressed configuration(as shown, for example, in FIG. 1) to a proximally orientedconfiguration in which the barbs 24 extend substantially in a directionalong the outer wall 30 of the catheter body 12. Such flexing actionpermits at least a portion of the anchor mechanism 22 to enter throughthe incision with a reduced likelihood of traumatizing the skin aroundthe incision.

Referring to FIG. 5, when the anchor catheter 10 is introduced into thepatient and during the treatment period, the catheter body 12 penetratesthe dermis 118 and subcutaneous layer 120. After the barbs 24 havepassed through the dermis 118, the barbs 24 can return partially orfully toward the unstressed configuration (as shown, for example, inFIG. 1) so as to deploy within the subcutaneous layer 120. For example,the subcutaneous layer 120 may comprise fatty tissue in which the barbs24 can move in a sweeping arcuate motion away from the catheter body 12.Such deployment in the subcutaneous layer 120 may releasably secure theanchor catheter 10 to the patient's body for the duration of the medicalprocedure. In this embodiment, the barbs 24 extend away from the outerwall 30 of the catheter body 12 with an curvature so that the tips ofthe barbs 24 are not necessarily pointed at the underside of the dermis118. Such a configuration may be accomplished, for example, by insertingthe barbs 24 further into the subcutaneous layer 120 and then moving thebarbs with a slight pulling motion to permit the barbs to sweepoutwardly from the catheter body 12. It should be understood that, dueto the vagaries of human anatomy and differing inward and outward forcesduring treatment, in some embodiments the orientation and position ofthe deployed barbs 24 may vary when deployed in the subcutaneous layer120. In some embodiments, the anchor mechanism 22 may provide a holdingforce of about 1 lb. or greater, depending upon the medical procedurebeing performed, the materials of the anchor mechanism 22 (e.g., anitinol material may be “programmed” to have particular bending forces,as described in more detail below), the geometry of the barbs 24, andother factors. For example, the anchor mechanism 22 may provide aholding force of about 1 lb to about 50 lbs, about 1 lb to about 20 lbs,about 1 lb to about 5 lbs, or about 2 lbs to about 3 lbs.

Referring to FIG. 6, the anchor catheter 10 may be removed from thepatient following completion of medical procedure. As a result of aremoval force applied to the catheter body 12 that overcomes the holdingforce of the anchor mechanism 22, the barbs 24 may be temporarily flexedfrom their deployed configuration (as shown, for example, in FIG. 5) toa distally oriented configuration in which the barbs 24 extendsubstantially in a direction along the outer wall 30 of the catheterbody 12. Such flexing action permits at least a portion of the anchormechanism 22 to exit through the incision in the patient's skin with areduced likelihood of traumatizing the skin around the incision. Forexample, the barbs 24 may have a curved configuration in which the tipsdo not point directly at the dermis 118) when deployed in thesubcutaneous layer 120 (refer, in one example, to FIG. 5). As such, theremoval force causes the barbs 24 to flex (rather than substantiallytear through the underside of the dermis 118) in a generally sweepingmotion toward the distally oriented configuration (refer, in oneexample, to FIG. 6). In the embodiments in which the barbs 24 comprise anitinol material exhibiting superelastic characteristics, the barbs 24can return toward the unstressed configuration (as shown, for example inFIG. 1) following removal of the anchor mechanism 22 from the skin. Insome alternative embodiments, the barbs 24 may comprise a biocompatiblepolymer material that is elastically or plastically deformed into thedistally oriented configuration (as shown, for example, in FIG. 6) as aresult of the removal force applied to the catheter body 12.

Referring to FIGS. 7-9, the anchor sleeve 100 previously described inconnection with FIGS. 3-3A may be introduced into a patient so that theanchor mechanism 110 may releasably secure the sleeve body 102 to thepatient. As previously described, the insertion force applied to thesleeve body 102 or other medical device may cause at least a portion ofthe anchor mechanism 110 to flex during insertion into a subcutaneousregion, and the removal force applied to the sleeve body 102 or othermedical device may cause at least a portion of the anchor mechanism 110to flex or deform during removal from the patient's skin. Thus, theanchor mechanism 110 may be self-actuated without the need for aseparate actuation device to extend or retract the barbs 112.

As shown in FIG. 7, the anchor sleeve 100 may be introduced into apatient prior to commencement of medical procedure or other treatment.For example, the anchor sleeve 100 may penetrate the dermis 118 and thesubcutaneous layer 120 through a small incision made by a physician. Asa result of an insertion force applied to the sleeve body 102 by thephysician, the barbs 112 may be temporarily flexed from their unstressedconfiguration (as shown, for example, in FIG. 1) to a proximallyoriented configuration in which the barbs 112 extend substantially in adirection along the outer wall 101 of the sleeve body 102. Such flexingaction permits at least a portion of the anchor mechanism 110 to enterthrough the incision with a reduced likelihood of traumatizing the skinaround the incision. During the medical procedure or other treatment, amedical device such as a catheter 116 may be slidably inserted into theanchor sleeve 100. Alternatively, the medical device such as thecatheter 116 may be inserted into the anchor sleeve 100 prior tointroducing the anchor sleeve into the patient.

Referring to FIG. 8, when the anchor sleeve 100 is introduced into thepatient and during the treatment period, the sleeve body 102 penetratesthe dermis 118 and subcutaneous layer 120. After the barbs 112 havepassed through the dermis 118, the barbs 112 can return partially orfully toward the unstressed configuration (as shown, for example, inFIG. 3) so as to deploy within the subcutaneous layer 120. As previouslydescribed, the subcutaneous layer 120 may comprise fatty tissue in whichthe barbs 112 can move in a sweeping arcuate motion away from the sleevebody 102. Such deployment in the subcutaneous layer 120 may releasablysecure the anchor sleeve 100 to the patient's body for the duration ofthe medical procedure. In this embodiment, the barbs 112 extend awayfrom the outer wall 101 of the sleeve body 102 with a curvature so thatthe tips of the barbs 112 are not necessarily pointed at the undersideof the dermis 118. Such a configuration may be accomplished, forexample, by inserting the barbs 112 further into the subcutaneous layer120 and then moving the barbs with a slight pulling motion to permit thebarbs 112 to sweep outwardly from the sleeve body 102. It should beunderstood that, due to the vagaries of human anatomy and differinginward and outward forces during treatment, in some embodiments theorientation and position of the deployed barbs 112 may vary whendeployed in the subcutaneous layer 120. In some embodiments, the anchormechanism 110 may provide a holding force of about 1 lb. or greater,depending upon the medical procedure being performed, the materials ofthe anchor mechanism 110 (e.g., a nitinol material may be “programmed”to have particular bending forces, as described in more detail below),the geometry of the barbs 112, and other factors. For example, theanchor mechanism 110 may provide a holding force of about 1 lb to about50 lbs, about 1 lb to about 20 lbs, about 1 lb to about 5 lbs, or about2 lbs to about 3 lbs.

Referring to FIG. 9, the anchor sleeve 100 may be removed from thepatient following completion of medical procedure. As a result of aremoval force applied to the sleeve body 102 by the physician, the barbs112 may be temporarily flexed from their deployed configuration (asshown, for example, in FIG. 8) to a distally oriented configuration inwhich the barbs 112 extend substantially in a direction along the outerwall 101 of the catheter body 102. Such flexing action permits at leasta portion of the anchor mechanism 110 to exit through the incision inthe patient's with a reduced likelihood of traumatizing the skin aroundthe incision. For example, the barbs 112 may have a curved configurationin which the tips do not point directly at the dermis 118) when deployedin the subcutaneous layer 120 (refer, in one example, to FIG. 8). Assuch, the removal force causes the barbs 112 to flex (rather thansubstantially tear through the underside of the dermis 118) in agenerally sweeping motion toward the distally oriented configuration(refer, in one example, to FIG. 9). In the embodiments in which thebarbs 112 comprise a nitinol material exhibiting superelasticcharacteristics, the barbs 112 can return toward the unstressedconfiguration (as shown, for example in FIG. 3) following removal of theanchor mechanism 110 from the skin. In some alternative embodiments, thebarbs 112 may comprise a biocompatible polymer material that iselastically or plastically deformed into the distally orientedconfiguration (as shown, for example, in FIG. 9) as a result of theremoval force applied to the sleeve body 102.

Referring now to FIG. 10, some embodiments of an anchor mechanism 200may be separately attachable to a catheter body, a sleeve body, oranother medical device that may require securing to a patient during atreatment period. The anchor mechanism 200 may include a base 202 andone or more barbs 204. In this embodiment, the anchor mechanism includestwo barbs 204 that extend away from one another. As previouslydescribed, some embodiments of the anchor mechanism 200 may be formedfrom a length of nitinol tubing from which a portion has been cut awayusing laser cutting, ECM, EDM, water jet or machining process. Also thebarbs 204 may be thermo-mechanically trained to extend away from theplane of an outer wall (not shown in FIG. 10) of the catheter body,sleeve body, or other medical device.

Referring to FIG. 11, some embodiments of an anchor mechanism 300 mayinclude a base 302 that is not continuous and has a gap 306. The anchormechanism may be separately attachable to a catheter body, a sleevebody, or another medical device that may require securing to a patientduring a treatment period. The anchor mechanism 300 may also include oneor more barbs 304, and in this embodiment, the anchor mechanism 300includes two barbs 304 that extend away from one another. The gap 306may permit the base 304 to be spread apart so as to wrap around someportion of the catheter body, sleeve body, or other medical device priorto introduction of the medical device into the patient. As previouslydescribed, some embodiments of the anchor mechanism 300 may be formedfrom a length of nitinol tubing from which a portion has been cut awayusing laser cutting, ECM, EDM, water jet or other machining process.Also the barbs 304 may be thermo-mechanically trained to extend awayfrom the plane of an outer wall (not shown in FIG. 10) of the catheterbody, sleeve body, or other medical device.

The anchor mechanisms 200 and 300 may operate in a manner similar to theembodiments shown in FIGS. 1-9. For example, the barbs 204, 304 may bemoved from the unstressed configuration (as shown, for example, in FIG.10 or 11) to a proximally oriented configuration (similar to that shown,for example, in FIG. 4 or 7) in response to an insertion force duringintroduction into the patient's skin through an incision. In anotherexample, when the attached catheter body, sleeve body, or other medicaldevice is in the treatment position (similar to that shown, for example,in FIG. 5 or 8), the barbs 204, 304 may return toward the unstressedconfiguration so as to deploy within the subcutaneous layer 120. In afurther example, the barbs 204, 304 may be moved from the unstressedconfiguration (as shown, for example, in FIG. 10 or 11) to a distallyoriented configuration (similar to that shown, for example, in FIG. 6 or9) in response to a removal force during removal from the patient'sskin.

Referring to FIG. 12, some embodiments of an anchor catheter 400 (orsleeve) may include anchor mechanism 404 having at least one atraumaticloop 410. The anchor mechanism 404 may be coupled to a catheter body 402(or a sleeve body) of the anchor catheter 400. The loop 410 may not havea free end and instead may be attached at one end to a slidable base 406and the other end to a second base 408, which may be fixed or slidable.In this embodiment, the second base 408 is fixedly coupled to thecatheter body 402. As shown in FIG. 12, the loop 410 may have anon-symmetric shape in which the first end (extending toward theproximal base 406) has a sharper curvature when in an unstressedconfiguration. The catheter body 402 may define a neck portion 402 ahaving a reduced diameter extending to a shoulder so that the slidablebase 406 may slide along the neck portion 402 a and may abut theshoulder. Thus, the slidable base 406 of the anchor mechanism 404 maymove in the longitudinal direction during insertion and removal of theanchor catheter 400. It should be understood that the neck portion 402 amay be long enough such that the slidable base 406 may be moved asufficient distance away from the second base 408 so that loop 410 doesnot protrude outward past the outer diameter of the catheter body 402.In such embodiments, the slidable base 406 and the second base 408 canbe disposed along the neck portion 402 a and may be configured to notprotrude beyond the outer dimension of the catheter body 402.

At least the atraumatic loop 410, and in some embodiments the entireanchor mechanism 404, is made from nitinol material which has beenprocessed to exhibit superelasticity below or at about a normal humanbody temperature, such as below or at about 37 degrees C. Suchsuperelasticity characteristics permit the atraumatic loop 410 toflexibly adjust during insertion into a subcutaneous region and toflexibly adjust during removal from the patient's skin. In somecircumstances, such flexing action may occur from the insertion andremoval force applied to the catheter body 402 or other medical device,without the need for a separate actuation device to adjust theatraumatic loop 410. As previously described, some embodiments of theanchor mechanism 404 may be formed from a length of nitinol tubing fromwhich a portion has been cut away using laser cutting, ECM, EDM, waterjet or other machining process. Also, the atraumatic loop 410 may bethermo-mechanically trained to extend away from the neck portion 402 a.It should be understood that, in the embodiments in which the loop 410comprises a nitinol material, the loop 410 may be formed from a lengthof nitinol wire or from a sheet of nitinol material. In some alternativeembodiments, the atraumatic loop 410 may comprise a biocompatiblepolymer material that is flexibly adjustable during insertion andremoval of the anchor mechanism 404. It should be understood that asimilar anchor mechanism 404 may be coupled to an anchor sleeve (notshown in FIG. 12) in a similar manner to the anchor catheter 400.

Referring to FIG. 13, the anchor catheter 400 may be introduced into apatient so that the anchor mechanism 404 may releasably secure thecatheter body 402 to the patient. As previously described, the insertionforce applied to the catheter body 402 or other medical device may causethe atraumatic loop 410 to flex during insertion into a subcutaneousregion. As shown in FIG. 13, the atraumatic loop 410 may shift from itsunstressed configuration (as shown, for, example, in FIG. 12) to anextended configuration so as to fit through a small incision made in thepatient's skin. This adjustment of the atraumatic loop 410 causes theslidable base 406 to shift toward the shoulder of the neck portion 402a. For example, the loop 410 may shift to the extended configurationwhen the insertion force causes the patient's dermis to act upon thesecond end of the loop 410. Alternatively, a physician may pull upon theslidable based 406 to force the loop into the extended configurationduring insertion of the loop into the subcutaneous layer 452.

After the anchor mechanism 404 is passed into the subcutaneous layer452, the atraumatic loop 410 may return towards its unstressedconfiguration (as shown, for example, in FIG. 12) so as to deploy theatraumatic loop 410 in the subcutaneous layer 452. In response to aremoval force applied to the catheter body 402, the atraumatic loop 410may flex to the extended configuration during removal from the patient'sskin. In one example, a physician may pull upon the slidable based 406to force the loop into the extended configuration during removal of theloop from the subcutaneous layer 452. Thus, the anchor mechanism 404 maybe self-actuated without the need for a separate actuation device toadjust the atraumatic loop 410. Further, the atraumatic loop 410 may notinclude exposed tip regions, thereby facilitating the removal of theanchor mechanism 404 with a reduced likelihood of traumatizing the skinaround the incision.

Referring to FIGS. 14-16, some embodiments of an anchor mechanism 500may include a barb 504 having a notch or other hinge configuration 506to facilitate the adjustment of the barb 504. The anchor mechanism 500may include a base 502 and one or more barbs 504. The base 502 at leastpartially extends around the attached catheter body, sleeve body, orother medical device. The hinge 506 may be formed proximate the point ofattachment between the base 502 and barb 504 so as to facilitatemovement of the barb 504 during introduction and removal of the attachedcatheter body, sleeve body, or other medical device. In this embodimentshown in FIG. 14, the hinge 506 is formed on the inner side of the barb504 (e.g., toward the attached medical device). FIG. 15 shows analternative embodiments of a barb 604 having the hinge 606 formed on theouter surface (e.g., away from the attached medical device). FIG. 16shows yet another embodiment of a barb 704 having at least a first hinge706 and a second hinge 708 formed on opposite sides of the barb 704. Inthese embodiments, one function of the hinge 506, 606, 706, 708 may beto provide a degree of control or predictability as to the location andthe threshold force level at which the barb 504, 604, 704 will flexduring introduction and removal of the attached medical device. In someembodiments, at least the barbs 504, 604, 704, and in some circumstancesthe anchor mechanism 502, may comprise a biocompatible polymer material,such as PEEK material, polyurethane material, polyethylene material,polyimide material, or another bio-compatible polymer material. In otherembodiments, at least the barbs 504, 604, 704, and in some circumstancesthe anchor mechanism 502, may comprise a metal material such as nitinol,stainless steel, spring steel, titanium, MP35N and other cobalt alloys,or the like. Alternatively, at least the barbs 504, 604, 704, and insome circumstances the anchor mechanism 502, may comprise a compositematerial such as polymer-coated nitinol or another biocompatiblecomposite material.

Referring to FIGS. 17-18, some embodiments of an anchor sleeve 800 (or,alternatively, an anchor catheter) may include an adhesive portion 806to secure a catheter or other medical device that is slidably engagedwith the lumen 804. The anchor sleeve 800 includes a sleeve body 802that defines a lumen 804. The lumen 804 may be a generally cylindricalconduit extending the length of the sleeve body 802. The adhesiveportion 806 may be used to secure the position of a catheter (or othermedical device) that is inserted into the anchor sleeve 800 eitherbefore or after the anchor sleeve 800 has been introduced into thepatient. In this embodiment, the adhesive potion 806 may include anadhesive layer that is revealed after removing a peel-away liner.

The sleeve body 802 may include a wall 808 having a thickness sufficientto receive at least a portion of one or more barbs 810. As such, thebarbs 802 may be embedded into the wall 808 of the sleeve body 802. Inthis embodiment, the stem portion of the barbs 810 may be integrallymolded with the wall 808, may be adhered into the wall 808, or may befrictionally engaged within a cavity formed in the wall 808. The barbsmay be formed to have a curvature so that the body of each barb 810 mayextend away from the outer surface of the wall 808. In some embodiments,each barb 810 is made from a nitinol material which has been processedto exhibit superelasticity below or at about a normal human bodytemperature, such as below or at about 37 degrees C. Suchsuperelasticity characteristics permit each barb 810 to flexibly adjustduring insertion into a subcutaneous region and to flexibly adjustduring removal from the patient's skin. In some circumstances, suchflexing action may occur from the insertion and removal force applied tothe sleeve body 802 or other medical device, without the need for aseparate actuation device to extend or retract the barbs 810.

Referring to FIGS. 19-20, some embodiments of an anchor sleeve 900 mayinclude a longitudinal gap 901 extending from the proximal end. Thelongitudinal gap 901 may permit an adhesive portion to be removablereceived in the lumen 904 of the sleeve body 902. Further, in somecircumstances, the longitudinal gap 904 may permit the sleeve body 902to be temporarily spread apart to wrap at least partially around acatheter or other medical device.

In some embodiments, an anchor mechanism 910 may be coupled to thesleeve body 902 by integrally molding with a sleeve body wall 908,adhering into the sleeve body wall 908, or frictionally engaging acavity formed in the sleeve body wall 908. The anchor mechanism 910 maycomprise a nitinol material that has been processed to exhibitsuperelastic or shape memory characteristics, a stainless steelmaterial, a spring steel material, titanium, MP35N and other cobaltalloys, a biocompatible polymer material, or composites thereof. Theanchor mechanism 910 may include one or more barbs 912 which extend fromthe sleeve body 902 and are able to flex against the outside surface ofthe sleeve wall 908. As shown in FIG. 20, the lumen 904 may be linedwith an adhesive portion 906 such that a release liner 916 can be peeledaway prior to use. In these embodiments, a physician may slide theanchor sleeve 900 over a catheter (or other medical device) and maydetermine the position along the catheter's length that subcutaneousanchor is desired. When the anchor sleeve 900 is disposed at the desiredposition along the catheter, the release liner 916 is removed to exposea pressure-sensitive adhesive layer 914. Then the anchor sleeve 900 issqueezed or compressed around the catheter to cause the anchor sleeve900 to be firmly attached for the duration of treatment. The anchorsleeve 900 and attached catheter (or other medical device) may then becontemporaneously introduced into the patient's skin. As previouslydescribed, each barb 910 may flexibly adjust during insertion into asubcutaneous region and may flexibly adjust during removal from thepatient's skin. In some circumstances, such flexing action may occurfrom the insertion and removal force applied to the sleeve body 902 orthe attached catheter (or other medical device), without the need for aseparate actuation device to extend or retract the barbs 910.

Referring now to FIGS. 21-22, some embodiments of an anchor sleeve 1000may include an anchor mechanism 1008 that is at least partially embeddedin the wall 1004 of the sleeve body 102. In this embodiment, the anchormechanism 1008 may be integrally molded with the wall 1004, may beadhered into the wall 1004, or may be frictionally engaged within acavity formed in the wall 1004. The anchor mechanism 1008 may comprise anitinol material that has been processed to exhibit superelastic orshape memory characteristics, a stainless steel material, a spring steelmaterial, titanium, MP35N and other cobalt alloys, a biocompatiblepolymer material, or composites thereof For example, the anchormechanism 1008 may be formed from a length of nitinol wire that isprocessed to exhibit superelastic characteristics below or at about anormal human body temperature (e.g., 37° C.). The anchor mechanism 1008may include one or more barbs 1010 which extend from the sleeve body1002 and are able to flex against the outside surface of the sleeve bodywall 1004. As shown in FIG. 21, the outer surface of the sleeve wall1004 may be provided with recesses 1012 which temporarily receive thebarbs 1010 during introduction of the anchor sleeve 1000. Such aconfiguration may reduce the likelihood of traumatizing the patient'sskin during insertion of the anchor sleeve through a small incision. Aspreviously described, the barbs 1010 may flexibly adjust duringinsertion into a subcutaneous region and may flexibly adjust duringremoval from the patient's skin. In some circumstances, such flexingaction may occur from the insertion and removal force applied to thesleeve body 1002 or other medical device, without the need for aseparate actuation device to extend or retract the barbs 1010.Optionally, a locking-hub device 1018, such as a Touhy-Borst adapter,may be disposed at a proximal portion of the sleeve body 1002 toreleasably retain a catheter or other medical instrument in a lumen 1006the sleeve body 1002.

Referring to FIG. 23, some embodiments of an anchor mechanism 1100 maybe separately formed and thereafter attached to a catheter body, asleeve body, or another medical device. The anchor mechanism 1100 mayinclude a base 1104 which is configured to have one or more apertures1106 extending through the base 1104. Extending from the base 1104 is atleast one barb 1102, which defines a free end and a fixed end that iscoupled to the base 1104. The anchor mechanism 1100 may comprise anitinol material that has been processed to exhibit superelastic orshape memory characteristics, a stainless steel material, a spring steelmaterial, titanium, MP35N and other cobalt alloys, a biocompatiblepolymer material, or composites thereof. The anchor mechanism 1100 isintended to be contained within a catheter wall (not shown) or an anchorsleeve wall (not shown) by such methods as integrally molding with thebody wall, adhering into the body wall, or frictionally engaging acavity formed in the body wall. As previously described, the barb 1102is capable of flexing or deforming sufficiently during insertion andremoval from the patient's skin so as to reduce the likelihood oftrauma, and the barb 1102 may be sufficiently rigid when deployed in thesubcutaneous region to secure the attached medical device (not shown) tothe patient's skin for the duration of the treatment.

Referring to FIG. 24, other embodiments of an anchor mechanism 1200 maybe separately formed and thereafter attached to a catheter body, asleeve body, or another medical device. The anchor mechanism 1200 mayinclude a base 1204 which is configured to have one or more apertures1206 extending through the base 1204. One or more barbs 1202 extend fromthe base 1204, each of which may include a free end. The anchormechanism 1200 may comprise a nitinol material that has been processedto exhibit superelastic or shape memory characteristics, a stainlesssteel material, a spring steel material, titanium, MP35N and othercobalt alloys, a biocompatible polymer material, or composites thereof.For example, the anchor mechanism 1008 may be cut from a sheet ofnitinol material that is processed to exhibit superelasticcharacteristics below or at about a normal human body temperature (e.g.,37° C.). The anchor mechanism 1200 is intended to be contained within acatheter wall (not shown) or an anchor sleeve wall (not shown) by suchmethods as integrally molding with the body wall, adhering into the bodywall, or frictionally engaging a cavity formed in the body wall. Aspreviously described, each barb 1202 is capable of flexing or deformingsufficiently during insertion and removal from the patient's skin so asto reduce the likelihood of trauma, and each barb 1202 may besufficiently rigid when deployed in the subcutaneous region to securethe attached medical device (not shown) to the patient's skin for theduration of the treatment.

A number of embodiments of the anchor mechanism or barbs have beendescribed. It should be understood that the anchor mechanisms 22, 110,200, 300, 404, 500, 910, 1100, 1200 or barb 604, 704, 810 could beinterchanged and incorporated with an anchor sleeve, anchor catheter, oranother elongated body configured to provide access through a patient'sskin.

In those embodiments in which the anchor mechanism of the barb comprisea nitinol material, at least a portion of the barb may be processed toexhibit superelastic or shape memory characteristics. For example,following formation of one of the various nitinol embodiments of theanchor mechanism 22, 110, 200, 300, 404, 500, 800, 910, 1008, 1100, 1200as described above, at least the barb 24, 112, 204, 304, 810, 912, 1010,1102, 1202 or securing loop 410 may undergo a shape-training processedso that the barb has a desired shape upon deployment in the subcutaneousregion. The shape-training process imparts superelasticity, as explainedin detail below, to at least the barb 24, 112, 204, 304, 810, 912, 1010,1102, 1202 and securing loop 410. In some embodiments, when the anchormechanism 22, 110, 200, 300, 404, 500, 910, 1008, 1100, 1200 or barb 810is cut or machined from its source material, it may then be placed in aforming jig that holds the barb 24, 112, 204, 304, 810, 912, 1010, 1102,1202 or securing loop 410 in the position in which it will eventually betrained. In certain embodiments, the anchor mechanism 22, 110, 200, 300,404, 500, 910, 1008, 1100, 1200 and barb 810 may be subjected to atemperature of 500 degrees C.+/−100 degrees C. for less than thirtyminutes, depending on the alloy chemistry, dimensions, fixturing andheat source (e.g., salt bath, hot air torch, oven, or the like). Aheavier and larger fixture may take a longer length of heat treatmenttime. Following heat treatment, the anchor mechanism 22, 110, 200, 300,404, 500, 910, 1008, 1100, 1200 and barb 810 may be quickly cooled, forexample, by an air fan.

As previously described, the anchor mechanism 22, 110, 200, 300, 404,500, 910, 1008, 1100, 1200 or barb 810 may be formed from nitinolprocessed to exhibit thermal shape memory characteristics at human bodytemperature. Nitinol is an approximate stoichiometric alloy of nickeland titanium; however, other elements such as vanadium are sometimesadded in small amounts to alter the mechanical characteristics of thealloy. Chemical composition and processing history primarily determinethe particular mechanical properties of a shape memory/superelasticmetallic alloy. In general, such an alloy will exist in either one orthe other, or combinations of two crystallographic phases. Austenite isthe parent crystallographic phase and exists at higher temperatures.Martensite is the other phase and is formed by either subjecting thealloy to lower temperatures or by placing mechanical or physical stresson the alloy while it is in the austenitic phase. Transitiontemperatures between these two phases can be experimentally determinedfor a particular alloy. Processing history includes high temperatureannealing as well as low temperature forming and deformation. Followingstandard material and processing specifications, the transitionaltemperatures that define the alloy's mechanical characteristics arepredictable and controllable. Standard transitional temperaturedesignations are given as: M_(s) for the start of the transition to themartensitic phase, M_(f) for completion of the transition to martensite,A_(s) for the start of the transition to the austenitic phase, and A_(f)for the completed transition to austenite.

It is believed that superelasticity is based on phase transition fromaustenite to martensite. Mechanically induced phase transition fromaustenite to martensite occurs when the alloy temperature is above A_(f)and a physical restraint is applied to the alloy. As long as therestraint is in place, the portion of the alloy receiving the stressreverts to the martensitic phase, which remains as long as the stress ismaintained. Unless the shape recovery limits are exceeded, when therestraint is removed and the stress is released the alloy returns to itsoriginal austenitic phase and shape as long as the temperature ismaintained above A_(f). Thus, when the austenitic, trained shape of thealloy is deformed and held by stress in a new shape, a certain amount offorce is exerted by the alloy against the restraint as it resists thenew, untrained shape.

These alloys may also exhibit a thermal shape memory effect. Thermalshape memory occurs as the result of a piece of shape memory alloy metalbeing deformed while in the lower temperature martensitic phase and thenbeing reheated to a temperature somewhere above A_(s) which causes thealloy to reform in the austenitic phase. When the crystallographicnature of the alloy is completely austenitic, the alloy's shape returnsto the previously trained shape. Shape memory training occurs when athermal shape memory/superelastic metallic alloy is annealed (orheat-treated) while restrained in a certain shape. The trained shapewill then be maintained unless it is deformed while in the lowtemperature martensitic phase. Upon reheating the alloy to theaustenitic phase, the original shape, which was “learned” in theannealing process, will be “remembered” and returned to. Thus,temperature change is one way of controlling the crystallographic phaseof a shape memory/superelastic metallic alloy.

One practical benefit of a shape memory/superelastic alloy overnon-superelastic materials is that it can be deformed to a far greaterdegree without taking a permanent set or kink. In the case ofsuperelastic alloys (e.g., alloys processed to exhibit superelasticityat body temperature), assuming the alloy is above the A_(f) temperature,removal of the restraint alone may be sufficient to resume the original,trained shape. When the alloy is processed to have shape memorycharacteristics, the martensitic phase alloy need only be subjected totemperatures somewhere above A_(f) and the alloy will eventually returnto its original, trained shape. It is also possible to use a restraintin conjunction with alloys trained to exhibit thermal shape memorycharacteristics.

Accordingly, when some embodiments of an anchor mechanism 22, 110, 200,300, 404, 500, 910, 1008, 1100, 1200 or barb 810 made of nitinol areprocessed to exhibit superelastic characteristics below or at about anormal human body temperature, it may employ superelasticity in twodifferent ways. First, superelasticity (stress-induced martensite)allows the anchor mechanism 22, 110, 200, 300, 404, 500, 910, 1008,1100, 1200 or barb 810 to be repeatedly deformed without taking apermanent set or kink. Secondly, the barb 24, 112, 204, 304, 810, 912,1010, 1102, 1202 or securing loop 410 can be processed as describedabove to “program” an estimated maximum amount of force that can beapplied before the barb 24, 112, 204, 304, 810, 912, 1010, 1102, 1202and securing loop 410 will begin to flex. The advantage to this propertyis that when an amount of force that has been predetermined to causelittle or no tissue damage to the patient's skin or subcutaneous layer,the barb 24, 112, 204, 304, 810, 912, 1010, 1102, 1202 or securing loop410 may be “programmed” to flex at this threshold level of force. Assuch, the barb 24, 112, 204, 304, 810, 912, 1010, 1102, 1202 or securingloop 410 will temporarily flex (as shown, for example, in FIGS. 4-6,7-9, and 12-13), allowing the physician to readily introduce or removethe device 10, 100, 200, 300, 400, 500, 800, 900, 1000 (and any attachedmedical device) with a reduced likelihood of traumatizing to thepatient's.

A number of embodiments of the invention have been described.Nevertheless, it will be understood that various modifications may bemade without departing from the spirit and scope of the invention.Accordingly, other embodiments are within the scope of the followingclaims.

1. (canceled)
 2. A method of anchoring a medical device to skin of apatient, the method comprising: inserting at least a portion of anelongate body through a dermis layer, the elongate body coupled with asubcutaneous anchor mechanism at a location proximal from a distal tipof the elongate body, wherein the subcutaneous anchor mechanismcomprises an atraumatic loop that flexibly adjusts from an unstressedconfiguration to an extended configuration during insertion, and whereinthe elongate body comprises a body wall that at least partially definesa lumen extending between a distal base portion and a proximal baseportion to receive a catheter therein; and removing at least a portionof the elongate body from the dermis layer so that the subcutaneousanchor mechanism flexibly adjusts from the unstressed configuration in asubcutaneous layer beneath the dermis layer to the extendedconfiguration when the anchor mechanism exits through the dermis layer,wherein the unstressed configuration is different from the extendedconfiguration, and wherein the proximal base portion slides along theneck portion and abuts the shoulder during at least one of: i) aninsertion of at least a portion of the elongate body through the dermislayer or the subcutaneous layer, and ii) a removal of at least a portionof the elongate body through the dermis layer or the subcutaneous layer.3. The method of claim 2, further comprising inserting at least aportion of the elongate body through a subcutaneous layer beneath thedermis layer, wherein the atraumatic loop flexibly adjusts from theextended configuration to the unstressed configuration when in thesubcutaneous layer.
 4. The method of claim 2, wherein inserting the atleast a portion of the elongate body comprises applying an insertionforce to the elongate body that flexes the atraumatic loop duringinsertion.
 5. The method of claim 2, wherein removing the at least aportion of the elongate body comprises applying a removal force to theelongate body that flexes the atraumatic loop to the extendedconfiguration during removal from the skin of the patient.
 6. The methodof claim 2, wherein inserting the at least a portion of the elongatebody comprises inserting the at least a portion of the elongate bodythrough a skin penetration point by a pushing force such that theatraumatic loop advances through the skin penetration point.
 7. Themethod of claim 6, wherein removing the at least a portion of theelongate body comprises withdrawing the atraumatic loop through the skinpenetration point by a pulling force such that the atraumatic loop isremoved through the skin penetration point.
 8. The method of claim 2,wherein the proximal base portion is movable relative to the distal baseportion.
 9. The method of claim 8, wherein a distance between theproximal base portion and the distal base portion when the atraumaticloop is in the unstressed configuration is less than the distance whenthe atraumatic loop is in the extended configuration.
 10. The method ofclaim 2, wherein the distal base portion, proximal base portion, and theatraumatic loop are integrally formed with one another as a unitarystructure.
 11. The method of claim 2, wherein the subcutaneous anchormechanism comprises a plurality of atraumatic loops.
 12. The method ofclaim 2, wherein the subcutaneous anchor mechanism comprises abio-compatible polymer material that is configured to elastically flexduring insertion through a skin penetration point and configured toelastically flex or plastically deform during withdrawal through theskin penetration point.
 13. The method of claim 2, wherein theatraumatic loop is permanently coupled to the distal base portion andthe proximal base portion.
 14. The method of claim 2, wherein thesubcutaneous anchor mechanism is configured to provide a holding forceof about 2 lbs. to about 3 lbs. when the atraumatic loop secures atubular catheter in the subcutaneous layer.
 15. A method of anchoring amedical device to skin of a patient, the method comprising: inserting atleast a portion of an elongate body through a dermis layer, the elongatebody coupled with a subcutaneous anchor mechanism at a location proximalfrom a distal tip of the elongate body, wherein the subcutaneous anchormechanism comprises an atraumatic loop that flexibly adjusts from anunstressed configuration to an extended configuration during insertion,and wherein the elongate body comprises a body wall that at leastpartially defines a lumen extending between a distal base portion and aproximal base portion to receive a catheter therein; and removing atleast a portion of the elongate body from the dermis layer so that theatraumatic loop flexibly adjusts from the unstressed configuration in asubcutaneous layer beneath the dermis layer to the extendedconfiguration when the subcutaneous anchor mechanism exits through thedermis layer, the unstressed configuration different from the extendedconfiguration, wherein the body wall includes a neck portion having areduced diameter that extends to a shoulder of an exterior of theelongate body, and wherein in the unstressed configuration, theatraumatic loop extends outwardly from the lumen a greater distance thanin the extended configuration.
 16. The method of claim 15, furthercomprising inserting at least a portion of the elongate body through asubcutaneous layer beneath the dermis layer, wherein the atraumatic loopflexibly adjusts from the extended configuration to the unstressedconfiguration when in the subcutaneous layer.
 17. The method of claim15, wherein inserting the at least a portion of the elongate bodycomprises applying an insertion force to the elongate body that flexesthe atraumatic loop during insertion.
 18. The method of claim 15,wherein removing the at least a portion of the elongate body comprisesapplying a removal force to the elongate body that flexes the atraumaticloop to the extended configuration during removal from the skin of thepatient.
 19. The method of claim 15, wherein inserting the at least aportion of the elongate body comprises inserting the at least a portionof the elongate body through a skin penetration point by a pushing forcesuch that the atraumatic loop advances through the skin penetrationpoint.
 20. The method of claim 19, wherein removing the at least aportion of the elongate body comprises withdrawing the atraumatic loopthrough the skin penetration point by a pulling force such that theatraumatic loop is removed through the skin penetration point.
 21. Themethod of claim 15, wherein the subcutaneous anchor mechanism isself-actuated to deploy in the subcutaneous layer without the need for aseparate actuation device to extend or retract the atraumatic loop.